Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE) (NCT06605508) | Clinical Trial Compass
RecruitingNot Applicable
Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)
United Arab Emirates30 participantsStarted 2025-01-10
Plain-language summary
The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra).
The main questions the study aims to answer are:
Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound?
Participants will:
Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis.
Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment.
Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.
Who can participate
Age range
30 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: Adult males aged 30 to 75 years.
* Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.
* Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.
* General Health: Overall good health without contraindications to stem cell therapy.
* Informed Consent: Ability and willingness to provide written informed consent to participate in the study.
Exclusion Criteria:
* Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease.
* Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant.
* Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes.
* Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy.
* Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety.
* Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant\'s ability to comply with study protocols or provide informed consent.
* Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the int…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Erectile Function as Measured by the International Index of Erectile Function (IIEF) Score